Kornimate/medical-research-clean huggingface dataset:
trial study of an exercise program for youth with persistent symptoms after concussion

Conditions: Concussion; Sport-Related Concussion; Mild Traumatic Brain Injury

Summary: the purpose of this randomized control trial study is to determine if an active rehabilitation (low intensity exercise program) in combination with a comprehensive education intervention (standard care) is more effective than the comprehensive education intervention alone in reducing post-concussion symptoms and improving participation in daily activities in youth who have persistent post-concussion symptoms.

there is a portion of youth who continue to experience persistent post-concussion symptoms beyond the first few weeks of injury. there is limited evidence with respect to the best ways to treat persistent post-concussion symptoms in youth following concussion. there is a small amount of literature that suggests active rehabilitation as a positive intervention for promotion of recovery of persistent post-concussion symptoms. however, this approach to rehabilitation has yet to be explored using a randomized control trial protocol. therefore, this study aims to answer the following question: is a 6 week active rehabilitation program in combination with a comprehensive education intervention (standard care) effective in reducing post-concussive symptoms and improving functional recovery compared to receiving comprehensive education intervention alone among youth experiencing persistent post-concussion symptoms? we hypothesize: 1. youth ages 10 to 18 years who present with persistent self-reported post-concussion symptoms 4 weeks after the initial injury and receive the active rehabilitation intervention, will present with decreased post-concussion symptoms at the completion of the intervention. 2. youth ages 10 to 18 years who receive the active rehabilitation intervention, will present with more complete functional recovery and increased participation in unrestricted physical activity at the completion of the active rehabilitation intervention compared to children receiving the comprehensive education intervention only

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of concussion * have at least one post-concussion symptom (as measured by the post concussion symptom inventory) * are at least 4 weeks post injury * between the ages of 10 and 18 years * ability to speak english * ability to demonstrate capacity to consent to study exclusion criteria: * prior moderate or severe brain injury * neck pain/dysfunction or oculormotor/vestibular dysfunction, developmental delays, mental health disorders or chronic pain conditions that prevent participation in active rehabilitation, assessment of gait and balance, or participation in cognitive testing * participating in any other physical rehabilitation interventions for post-concussion symptoms (e.g., physiotherapy, massage therapy, chiropractic) at time of enrollment and throughout the duration of the study

Keywords: concussion persistent symptoms children exercise adolescents active rehabilitation education
influence of exercise on anemia in mds patients

Conditions: Feasibility Pilot Study

Summary: that exercise will reduce anemia and fatigue, while improving aerobic capacity, strength and hematopoietic stem and progenitor cell mitochondrial function.


Eligibility criteria:
inclusion criteria:have a confirmed diagnosis of mds, have approval of the study medical monitor, be able to read english, be 21 years of age or older, give informed consent - exclusion criteria: have physical limitations, be identified in the active or maintenance stage of exercise behavior -
trial evaluating safety, tolerability and immune response of ag-707

Conditions: Genital Herpes

Summary: this is a randomized, multi-center, sequential, dose-escalating study of three dose cohorts of ag-707. individuals who meet all of the inclusion and exclusion criteria for eligibility will be randomized to receive either ag-707 (at the 80 µg dose), ag-707 with qs-21 (at the 80 µg dose), placebo, or qs-21. each patient will be monitored for safety as specified in the protocol.

primary objective: determine the overall safety profile of three different dose levels of ag-707 vaccination (with and without an adjuvant, qs-21) at 80, 240 and 400 µg compared to placebo and qs-21 alone in hsv-2 seropositive adults. secondary objective: determine immune response to ag-707 vaccination (with and without qs-21) at dose cohorts of 80, 240, and 400 µg as compared to placebo and qs-21 alone.

Eligibility criteria:
inclusion criteria: * patients must be seropositive for hsv-2 (+/- hsv-1) and have a documented history of clinically active genital herpes (at least one prior outbreak). * patients must be seronegative for hiv. * patients must be seronegative for hepatitis b and c * have baseline chemistry and hematology (hemoglobin, white blood cell (wbc), absolute neutrophil count (anc), eosinophils) within normal limits; prothrombin time (pt) and partial thromboplastin time (ptt) below the upper limit of normal (uln), and platelets above the lower limit of normal (lln). basophils, lymphocytes and monocytes must be within 1.2 x uln or 0.8 x lln and considered not clinically significant by the investigator. total creatine phosphokinase (cpk) laboratory values \< 1.25x the upper limit of normal (according to the normal reference ranges of the central laboratory) at baseline (screening and pre-study visit) and considered not clinically significant by the investigator. * patients must not be taking antiviral therapy. * must be between the ages of 18 and 50 years of age and willing to either use an effective method of contraception or abstain from sexual activity for the 28-week duration of the trial. exclusion criteria: * severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the principal investigator, would prevent study completion. * history of hsv infection of the eye (herpes simplex interstitial keratitis or uveitis), or herpes-associated erythema multiforme. * history of immune suppression or autoimmune disorder. * concomitant use of systemic corticosteroids or other immunosuppressive medications (including nasal and inhaled steroids). the use of nasal steroids for seasonal rhinitis is acceptable. * patients with known hypersensitivity or allergies to acyclovir or valacyclovir.

Keywords: genital herpes hsv-2 seropositive vaccine
effects of a high or low salycilate diet on urinary lte4 and clinical features in aerd

Conditions: Aspirin-exacerbated Respiratory Disease; Aspirin-Sensitive Asthma With Nasal Polyps; Samter's Syndrome; Widal Syndrome

Summary: on day one, two groups of nine patients each will respectively recieve the tree daily meals (breakfast, lunch and dinner) in a controled clinical setting. group 1 will recieve a low-salycilate diet, and group 2 a high-salycilate diet. two hours after each meal, urinary leucotriene e4, fev1, fvc, fev1/fvc and total nasal resistance will be measured. on day 7, after clearance time, group 1 will recieve high-salycilate diet and group 2 low salycilate diet and the same measurements will be obtained.


Eligibility criteria:
inclusion criteria: * confirmed aspirin exacerbated respiratory disease. * controled asthma * no actual systemic corticosteroid treatment * no antileucotriene treatment. exclusion criteria: * patients who do not complete both phases of the study * patients unable to perform adecuate spyrometric testing * patients who present severe asthmatic reactions with high salycilate foods
comparison of early operative treatment and 48 h conservative treatment in small bowel obstruction

Conditions: Small Bowel Obstruction; Small Bowel Adhesion; Strangulation of Ileum

Summary: this study will compare the results of early surgery after 12 h conservative treatment and 48 h conservative treatment of adhesive small bowel obstruction.

at the admission patients undergo abdomen x-ray, general and biochemical blood test and computer tomography (ct). after exclusion of indications for an emergency operation, patients are given a water-soluble contrast. conservative treatment is carring out to 12 hours from admission. all patients with resolution of small bowel obstruction in 12 hours will be excluded from the research. criteria for obstruction release of conservative treatment 1. no pain 2. appearance of gas in the colon 3. decrease of bloating 4. contrast in the colon. after that, if obstruction is not resolved, randomization is performed. first group undergo surgery. second group undergo conservative treatment with water-soluble contrast evaluation until 48 hours. in the second group surgery is performed if the conservative treatment is not effective. the results of early and late surgery and the results of conservative treatment in groups will be compared.

Eligibility criteria:
inclusion criteria: patients with adhesive small bowel obstruction exclusion criteria: early postoperative small bowel obstruction irreducible hernia strangulation or peritonitis symptoms impairment of consciousness unstable hemodynamics

Keywords: conservative treatment laparoscopic adhesiolysis strangulation
a 12week, randomized, evaluator-masked, parallel group comparing evening dosing of xalacom vs cosopt in subj w/ glaucoma

Conditions: Glaucoma, Open Angle; Ocular Hypertension

Summary: to demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 am, 12 noon \& 4 pm during a 12 week treatment.


Eligibility criteria:
inclusion criteria: * uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening exclusion criteria: * closed/ barely open anterior chamber angle or history of acute angle closure glaucoma. * history of alt (argon laser trabeculoplasty) or slt(selective laser) within 3 months prior to screening
predicting response to intra-articular corticosteroid injection in patients with osteoarthritis of the glenohumeral joint

Conditions: Osteoarthritis of the Glenohumeral Joint

Summary: this study will examine the effectiveness of a single cortisone injection in patients with shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors to help predict how a patient with shoulder osteoarthritis will respond to a cortisone injection utilizing ultrasound guidance.

the purpose of this study is to assess the effectiveness of intraarticular corticosteroid injections (iacsi) for glenohumeral arthritis by 1) through patient-reported outcomes and 2) identifying clinical and radiographic predictors of iacsi success.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of symptomatic primary osteoarthritis of the shoulder will be recruited from the patient population seeking treatment at the orthopaedics sports medicine institute. * those who have failed previous treatment including over-the-counter analgesics and activity modification * have elected to receive a medically-indicated, ultrasound-guided iacsi in the shoulder. exclusion criteria: * patients will be excluded from the study for any of the following reasons: * post traumatic osteoarthritis * inflammatory osteoarthritis * imaging confirmed rotator cuff tear * prior ipsilateral shoulder surgery * memory loss or inability to complete study measures * history of allergy to injection medications * diabetic patients with patient-reported fasting blood glucose \>200 * prior injection in the ipsilateral shoulder within three months
ultrasound assisted lumbar puncture in the neonate

Conditions: Lumbar Puncture

Summary: clinicians are often unable to successfully do a spinal tap. ultrasound has been proposed as a method to improve success but it is not known if it helps. this study is designed to see if ultrasound improves the success rate.

obtaining cerebrospinal fluid (csf) through a lumbar puncture (lp) is an essential procedure in the neonatal/infant intensive care unit (n/iicu) for establishing diagnosis and determining treatment. the traditional technique for performing an lp involves palpation of anatomic landmarks followed by a "blind" stick of the appropriate inter-spinous process space. this technique has a failure rate (defined as the inability to obtain cerebrospinal fluid or obtaining a traumatic puncture) of 15-50%. bedside ultrasonography possesses the ability to visualize the anatomic landmarks, including the subarachnoid space. in the adult literature, ultrasound has been shown to reduce the lp failure rate. its utility has also been shown to significantly improve success rates and accuracy in epidural needle placement in neonates and children undergoing regional anesthesia. increasing the proportion of successful lps in the n/iicu could significantly reduce patient/family discomfort, sedation exposure, off unit travel, additional interventional procedures and antibiotic use. however, research on the utility of bedside ultrasound assisted lps by clinicians working in an n/iicu is lacking. this is a prospective randomized controlled trial. eligible subjects will be randomized to undergo lp (performed as part of their standard of care) with ultrasound assisted method or traditional landmark method. primary objective: -to determine if bedside ultrasound-assisted lp, performed by n/iicu clinicians on neonates and infants aged ≤6 months, increases the proportion of successful first attempt non-traumatic lps when compared to a traditional landmark palpation technique. secondary objectives: * to determine if bedside-ultrasound assisted lps increases the proportion of overall successful non-traumatic lps within 2 attempts. * to determine if bedside-ultrasound assisted lps is associated with a decrease in the length of antibiotic exposure in patients undergoing lps.

Eligibility criteria:
inclusion criteria: 1. neonates and infants aged ≤6 months 2. clinical indication for a lumbar puncture (lp), as determined by the clinical team 3. availability of study personnel to perform bedside ultrasound exclusion criteria: 1. known spinal cord abnormality (for e.g., tethered cord, spina bifida) 2. presence of skin and soft tissue infection at insertion site 3. recent failed lp traumatic lp attempts within the preceding 48 hours 4. recent diagnosis of intraventricular hemorrhage, within the preceding 7 days 5. clinically unstable patient, as determined by the clinical team 6. eligible patients on the resident care team

Keywords: ultrasonography infant newborn lumbar puncture spinal puncture cerebrospinal fluid
effects of greenselect phytosome® on weight maintenance after weight loss in obese women

Conditions: Obesity

Summary: this study evaluates whether supplementations with a highly bioavailable green tea extract may help obese women to counteract weight regain after a 3-month weight loss intervention.

most obese subjects regain weight after weight loss due to compensatory adaptations finalized to maintain stable body energy stores. in lean or obese individuals, maintenance of a 10% or greater reduction in body weight is associated with a decline in 24-hour energy expenditure of approximately 20%-25%. the restraint of the energy expenditure decline during dieting by green tea (gt) preparations should be a useful strategy to facilitate weight maintenance. to increase absorption of gt, the investigators used a formulation with phospholipids (greenselect phytosome® ) added with piperine, a thermogenic agent and a booster of absorption for various phenolics. at the end of a 3-month lifestyle intervention, all patients giving written informed consent were randomly assigned to two groups for the weight-maintenance phase: 20 of them were supplemented twice a day for 3 months with a dietary supplement (globes®, pharmextracta, pontenure, piacenza, italy) and 20 with placebo.women were blind to the supplementation throughout the whole trial. all women attended a monthly clinical visit during the supplementation period and 3 months after the end of supplementation.

Eligibility criteria:
inclusion criteria: * outpatient * ≥18 years of age * body mass index (bmi) ≥ 30 kg/m2 * a sufficient level of education to understand study procedures and be able to communicate with site personnel exclusion criteria: * breast feeding or pregnancy * history of cardiovascular or cerebrovascular events * uncontrolled hypertension

Keywords: green tea weight maintenance obesity fat mass
evaluation of serum procalcitonin rate in patients with stage iv non-small cell lung cancer in first line chemotherapy

Conditions: Non Small Cells Lung Cancer

Summary: treatment of a stage iv nsclc is based on chemotherapy and requires before each session to check clinically, biologically and radiologically absence of infection. this biological evaluation is based on the crp rate. lots of infections may occur in this situation and could reduce by three the patient's life duration. however it is very important to make as early as possible a correct diagnosis of infection. crp rate is classically higher for those patients even without any infection. in comparison with crp, procalcitonin (pct) is well-known for its better sensibility and specificity for the infection diagnosis but has never been study in case of active cancer. the aim of this study is to evaluate the procalcitonin basal rate for those patients suffering from nsclc. it could be a simple and reliable method to use. so the investigators decided to include each new patient with nsclc stage iv coming for his first-line chemotherapy without any infection sign, and to realize a procalcitonin dosage before the start of the treatment. this sample will be analyzed at the chemical laboratory and the result will not be communicated to the patient physician. a new clinical evaluation will be realized either at the hospital or by phone at day 7 to search any sign of infection. in absence of infection, patient will be reevaluated at day 14, 21 and 30. in case of infection, a new procalcitonin (and crp) dosage will be performed.


Eligibility criteria:
inclusion criteria: * patient with stage iv nsclc, hospitalized for his first seance of chemotherapy * medical conditions permitting chemotherapy * informed consent signed * patient covered by social insurance exclusion criteria: * patient with small cell lung cancer * patients with nsclc stage i, ii or iii of the tumor node metastasis classification * patient with stage iv nsclc, who received prior treatment (radiotherapy, chemotherapy ...) * patient with infection (on clinical and paraclinical criteria) not compatible with the administration of the first seance of chemotherapy. * pregnant or breastfeeding women private patient freedom or in a position to judicial protection (guardianship)

Keywords: non small cells lung cancer procalcitonin
healthy prebiotic and postbiotic effects of peanuts and peanut butter: college intervention trial

Conditions: Microbiota; Cognitive Change

Summary: nuts have a prebiotic effect mainly due to their content of fiber and polyphenols, which provide substrates for the human gut microbiota. it is known that prebiotic substances are metabolized by microbiota generating postbiotics substances (products or metabolic by-products secreted by live bacteria or released after bacterial lysis). these products may improve host health and partly explain the health benefits of nut consumption. however, no study has been performed about the pre- and postbiotic effects of peanut and peanut butter consumption. therefore, researchers propose a new interventional study to assess the impact of daily peanut and peanut butter intake on the organism, evaluating the pre- and postbiotic effects. the metabolome data generated will be correlated with the beneficial effects and cognitive skills. the final aim of this work is to spread a message of the health benefits of peanut consumption for the general population.

to evaluate the possible changes in microbiota and cognitive skills after consumption of roasted peanuts and peanut butter, a three-arm parallel-group randomized, and controlled study is being carried out. ninety healthy college students were enrolled, according to the sample size estimated. blood, urine, feces and saliva are being drawing at baseline, 3 and 6 months. peripheral blood mononuclear cells are being extracted to evaluate the metabolic changes caused by the proposed nutritional interventions. to assess diet and physical activity a 151-items food frequency questionnaire plus a 7-day dietary record and a validated questionnaire minnesota are being used. to determinate the effects of the intervention on body composition and vascular risk factors, anthropometric, biochemical and clinical measurements are being collected. possible changes in cognitive skills will be determined from a validated cognitive questionnaire (wais-iv, wechsler memory scale-iv (wms-iv), cope and had). to evaluate inflammation and metabolic status before and after intervention, levels of hormones and signaling molecules will be analyzed in blood samples. the effect of roasted peanut and peanut butter consumption on microbiota will be assayed through identification and quantification of polyphenols and short-chain fatty acids in biological samples, as well as the gut microbiota characterization from dna extraction.

Eligibility criteria:
inclusion criteria: - healthy college students (aged between 18 and 32 years) exclusion criteria: * history of pathological conditions (cardiovascular diseases, cancer, diabetes and other chronic diseases) * alteration of clinical parameters (cholesterol, triglycerides and other markers) * peanut allergy or intolerance * use of dietary supplements or drugs * unusual dietary habits * usual consumption of wine and grapes * alcohol intake (\>30 g/day in males and \>20 g/day in females) * smokers * bmi \ 25

Keywords: peanuts peanut butter microbiota cognitive skills polyphenols short-chain fatty acids inflammation vascular